Roxatidine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Peptic ulcer 150 mg at bedtime or 75 mg twice daily for 4-6 wk. Maintenance: 75 mg at bedtime. GERD 75 mg twice daily or 150 mg at bedtime for 6-8 wk. Gastritis 75 mg once daily in the evening. Zollinger-Ellison syndrome 75 mg twice daily. Anesth pre-med 75 mg in the evening one day pre-op and repeated 2 hr before induction of anesth. IV Upper GI haemorrhage 75 mg twice daily.
Dosage Details
Intravenous
Upper gastrointestinal haemorrhage
Adult: 75 mg bid via slow inj or infusion.

Oral
Zollinger-Ellison syndrome
Adult: 75 mg bid.

Oral
Gastro-oesophageal reflux disease
Adult: 75 mg bid or 150 mg at bedtime for 6-8 wk.

Oral
Premedication before anaesthesia
Adult: 75 mg in the evening on the day before surgery and repeated 2 hr before induction of anaesthesia. Alternatively, 150 mg once on the night before surgery.

Oral
Peptic ulcer
Adult: 150 mg at bedtime or 75 mg bid daily for 4-6 wk. Maintenance: 75 mg at bedtime.

Oral
Gastritis
Adult: 75 mg once daily in the evening.
Renal Impairment
Oral:
Zollinger-Ellison syndrome:
CrClDosage
<2075 mg every 2 days.
20-5075 mg at bedtime.
Gastro-oesophageal reflux disease:
CrClDosage
<2075 mg every 2 days.
20-5075 mg at bedtime.
Peptic ulcer:
CrClDosage
<2075 mg every 2 days.
20-5075 mg at bedtime.
Gastritis:
CrClDosage
<2075 mg every 2 days.
20-5075 mg at bedtime.
Contraindications
Lactation. Porphyria.
Special Precautions
Renal and hepatic impairment, pregnancy. May mask the symptoms of gastric malignancy.
Adverse Reactions
Occasional headache, GI disturbances, gynaecomastia, alopecia, blood dyscrasias, pancreatitis, sleep disturbances, restlessness, rarely dizziness. Hypersensitivity reactions e.g. rash and itching reported occasionally. Changes in pulse rate and transient impairment of sexual drive. Possible increase in liver enzyme activity. May reduce leucocytes and/or thrombocytes.
Drug Interactions
May affect serum levels of protease inhibitors.
Action
Description: Roxatidine is a potent and selective inhibitor of basal and stimulated gastric acid secretion through competitive blockade of H2-receptors. Total pepsin secretion is reduced in a dose-dependent manner. There is an independent mucosal protection action.
Pharmacokinetics:
Absorption: Absorbed rapidly and almost completely from the GI tract (oral); peak plasma concentrations after 1-3 hr.
Distribution: Enters breast milk (small amounts).
Metabolism: Liver, small intestines and serum; hydrolysed to the desacetyl metabolite.
Excretion: Via urine (90% as roxatidine and metabolites); 6 hr (elimination half-life).
Disclaimer: This information is independently developed by MIMS based on Roxatidine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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